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Behavioural Intervention
SMS Chatbot Support for Gastrointestinal Cancer
N/A
Recruiting
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Capecitabine ONLY
* Capecitabine concurrent with Radiation Therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
No Placebo-Only Group
Summary
This trial focuses on using capecitabine, an oral chemotherapy drug, for cancer patients who manage their treatment at home. The goal is to help these patients take their medication correctly and manage side effects better. Capecitabine works by stopping cancer cells from growing and spreading and is used in the treatment of various cancers, including advanced breast and colorectal cancer.
Who is the study for?
This trial is for patients with gastrointestinal cancers who are taking oral chemotherapy, specifically capecitabine alone or in combination with other treatments like oxaliplatin, temozolomide, radiation therapy, or mitomycin.
What is being tested?
'Penny' is a chatbot delivered via the Memora Platform designed to help these patients manage their medication schedules and side effects. The study aims to improve adherence to complex oral chemotherapy regimens and better handle toxicity by providing remote guidance and monitoring.
What are the potential side effects?
While 'Penny' itself doesn't cause side effects, it helps manage those from oral chemotherapies like capecitabine which can include digestive issues, fatigue, hand-foot syndrome (redness/pain/swelling of hands/feet), and blood count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Medication Compliance - Will assess accuracy of medication reminders to patients and patient adherence to prescribed medication dosing and schedule
Patient Engagement with the Penny chatbot
Patient Safety of the Patient - Penny Chatbot interactions with patients will be assessed for accuracy of medication directions and triaging of symptoms reported and number of incorrect interactions between Penny and Patients will be measured.
Secondary study objectives
Patient Satisfaction with the Penny chatbot interactions will be measured by the Promoter Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Penny, a SMS Text-based chatbot interventionExperimental Treatment1 Intervention
This is a single arm study. All recruited patients will be entered on the Penny SMS Text-based chatbot intervention.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for gastrointestinal cancer, such as capecitabine, work by interfering with the DNA synthesis of cancer cells, thereby inhibiting their growth and proliferation. Capecitabine is an oral prodrug that is metabolized into 5-fluorouracil (5-FU) in the body, which then incorporates into the DNA and RNA of cancer cells, disrupting their function and leading to cell death.
This mechanism is crucial for GI cancer patients as it allows for targeted therapy that can be administered at home, offering convenience and autonomy. However, the complexity of dosing and the potential for significant side effects necessitate careful monitoring and adherence to ensure efficacy and minimize toxicity.
Understanding these mechanisms helps patients appreciate the importance of following their treatment regimen precisely and reporting any adverse effects promptly.
[Therapeutic adherence to oral cancer therapy and interdisciplinary management].
[Therapeutic adherence to oral cancer therapy and interdisciplinary management].
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,295 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
418 Previous Clinical Trials
464,062 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and being treated for GI cancer with specific medications.
Research Study Groups:
This trial has the following groups:- Group 1: Penny, a SMS Text-based chatbot intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.